Federal Institute for Risk Assessment

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Federal Institute for Risk Assessment
- BfR -

Federal Institute for Risk Assessment logo.svg
State level Federation
legal form Fully legal institution under public law
Supervisory authority Federal Ministry of Food and Agriculture
founding November 2002
Headquarters Berlin-Jungfernheide , Germany ( coord. ) Other locations: Berlin-Marienfelde ( coord. ), Alt-Marienfelde ( coord. )

Authority management Andreas Hensel , President
Servants 1075 (2020)
Web presence www.bfr.bund.de
The BfR location in Berlin-Jungfernheide
Aerial photo of the BfR location in Berlin-Marienfelde ( coordinates )

The Federal Institute for Risk Assessment ( BfR ) is a federally direct legal institution under public law of the Federal Republic of Germany . The institute is assigned to the division of the Federal Ministry of Food and Agriculture (BMEL) and has the task of scientifically advising the federal government on questions of food safety , product safety, contaminants in the food chain, animal welfare and consumer health protection . Further technical supervision is carried out by the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety ( chemical safety , environmental contaminants in food and feed) and the Federal Ministry for Transport and Digital Infrastructure ( dangerous goods transport , international ballast water agreement, emergency command ).

Areas of responsibility

The work of the institute is based on several pieces of legislation - i.a. a. to the BfR Act, the Food and Feed Code (LFGB), Infection Protection Act (IfSG), Plant Protection Act , Chemicals Act , Detergents and Cleaning Agents Act , Genetic Engineering Act .

The BfR, like the Federal Office for Consumer Protection and Food Safety (BVL) , was founded in 2002 as part of a reorganization of consumer health protection and food safety after the BSE crisis. It emerged from the Federal Institute for Consumer Health Protection and Veterinary Medicine and from parts of the Federal Biological Institute. The BfR has more than 800 employees.

According to the Establishment Act, the institute prepares assessments independently of politics. According to this, it is not subject to any specialist supervision in matters of scientific risk assessments. Consequently, it assumes a scientific reference and orientation function for unresolved scientific questions and in crises. This affects consumers, politics (the federal government and the federal states), economy, media, but also associations and science.

The three main task areas of food safety , product safety and chemical safety include the following questions. The institute is the contact person for

  • Questions about the biological safety of food such as zoonoses (these are pathogens such as salmonella that can be transmitted from animals to humans), their research, transmission routes and distribution
  • Questions about microbial toxins, for example in mussels or about antibiotic resistance of germs
  • Food hygiene questions
  • Questions about food ingredients such as coumarin in cinnamon or the formation of benzene in carrot juice (food toxicology)
  • Questions about nutritional risks, for example from food supplements , about allergies or functional foods such as plant sterols in spreadable fats to lower the cholesterol level
  • Questions about genetically modified foods
  • Questions about the pollution of food by environmental toxins such as dioxins , polychlorinated biphenyls (PCB) or polycyclic aromatic hydrocarbons (PAH)
  • Questions about feed safety
  • Questions about pesticides and biocides
  • Questions about poisoning
  • Questions about the safe transport of toxic substances
  • Questions about nanotechnology in food, consumer goods or cosmetics
  • Questions about the safety of cosmetics, textiles, toys, water pipes, food packaging and other consumer products
  • Questions about alternative methods to animal experiments

The BfR is a member of the working group of departmental research institutions . The responsible office is located in Berlin, Alt-Marienfelde ( coordinates ).


In addition to the management area with its staff units, the BfR currently has nine departments.


The administration is the service provider for all departments of the institute, it takes care of the infrastructure, the personnel recruitment, the support of the employees in personnel matters, the management and control of the income and expenses as well as the equipment and the organizational and technical maintenance of the rooms and the institute's premises. The purchase of equipment, materials and furniture is also prepared, coordinated and organized in the administration. The department issues organizational regulations for the institute and concludes service agreements with the staff council and contracts with external service providers. In addition, the administration controls and coordinates the institute's staffing requirements according to the positions allocated in the budget.

At the same time, the administration is responsible for compliance with legal regulations. This applies in particular in the personnel area for civil servants' law, collective bargaining and labor law, in the budget for the provisions of budget law and in procurement for the procurement regulations in the public service. Employment disputes are handled by the HR department, legal disputes with external parties are handled by the legal department.

The administration at the BMEL works together with the administration department there and supports the personnel and organization department as well as the budget department.

Department 1 includes the following units:

  • Unit 11: Human Resources
  • Unit 12: Budget
  • Unit 13: Organization
  • Unit 14: Procurement
  • Unit 15: Internal Services
  • Unit 16: Construction and Technology
  • Unit 17: Legal Services

Risk communication

Consumer health protection involves researching, assessing and communicating risks. However, not only actual risks are important here, but also how they are communicated in the media and the subjectively shaped perception of risks. Scientific knowledge must be conveyed in a transparent and understandable manner in order to promote the rational handling of risks.

The BfR has the statutory mandate to communicate risks and inform the public about possible health risks and the underlying research results in the field of food, chemicals and product safety. In doing so, they enter into an active dialogue with various contacts from science, business, politics, the media, associations, non-governmental organizations and consumers. In addition to target group-specific press and public relations work, this communication process also includes the active involvement of various interest groups through expert discussions, status seminars, consumer protection forums, stakeholder conferences and public symposia

The interdisciplinary risk communication department carries out research projects on the perception of risks, the early detection of risks and the assessment of their consequences, for example in the area of ​​new technologies such as nanotechnology, changes in the eating habits of consumers after risk communication or the prioritization of risks by various social interest groups. Representative surveys, consumer conferences, Delphi surveys and focus groups are used as instruments.

Another focus of the work is the coordination and the targeted expansion of national and international networking of the institutions responsible for consumer health protection in politics and science.

The risk communication department is divided into four specialist groups:

  • Crisis prevention and coordination
  • Risk research: awareness, early detection, impact assessment
  • Press / public relations
  • academy


The central task of the Exposure Department is the analysis, modeling and assessment of consumer exposure for the undesirable substances and microbiological hazards to be assessed by the BfR. According to the definition: risk = hazard x exposure, the BfR carries out an exposure assessment for each risk assessment, i. This means that it is checked whether and in what concentration the consumer has access to dangerous noxae. The exposure thus describes the magnitude of a risk. The department also performs a large number of scientific service functions for the BfR.

The following specialist groups are established in the department: "Safety during transports and coordination REACH", "Poisoning and product documentation", " Epidemiology ", "Statistics and mathematical modeling", "Exposure estimation and standardization", "Information technology" and "GLP federal agency (Federal Agency for Good Laboratory Practice) and quality management ”.

Some of the department's services are also available to external scientists, such as the registration and evaluation center for poisoning and the GLP federal agency.

Biological safety

As part of the legal mandate of risk assessment in the field of food safety and consumer protection, the Biosafety Department deals with health risks for humans, in particular from microorganisms, the toxins they produce and other microbial metabolic products. These include bacteria, yeasts and molds, but also viruses, parasites and TSE pathogens.

Not only food, but also feed and commodities (e.g. devices for processing food, food packaging materials, tableware) and cosmetics including the processes of their extraction, production, processing and distribution as carriers of biological hazards are included in the considerations.

The tasks include diagnostic methods for the detection of the various pathogens in food, their virulence and resistance properties, work on the prevalence of microbiological hazards in food and qualitative and quantitative risk assessments. The department contributes to the clarification of outbreaks through foodborne diseases and zoonoses (legally anchored task in the Infection Protection Act). A number of reference laboratories and consulting laboratories for the diagnosis and fine characterization of pathogens, for antibiotic resistance and for the microbiological contamination of food (task anchored in food and zoonosis law) are located in the department.

In addition, the collection of data from the monitoring for the preparation of the annual zoonoses trend report is carried out and coordinated at national and European level.

Department 4 includes the following seven specialist groups:

  • Division 41: Food technology processes, product chains and product protection
  • Section 42: Food Hygiene and Virology
  • Unit 43: Epidemiology, Zoonoses and Antibiotic Resistance
  • Division 44: Microbial Toxins
  • Section 45: Diagnostics and Pathogen Characterization
  • Unit 46: Molecular Microbiology and Genome Analysis
  • Section 47: Product Hygiene and Disinfection Strategies

Food safety

The food safety department evaluates food with regard to its material risks. The substances to be evaluated can naturally be contained in the food as ingredients or added to the food as food additives and flavorings. Undesired substances (contaminants, nanoparticles) that get into food through manufacturing, storage or treatment processes are also assessed. The department also assesses food according to nutritional criteria. The department gives its opinion on nutritional risks and questions of nutritional prevention. In addition, risks to particular population groups are assessed. Another focus of the department is the preparation of opinions in the field of novel foods as well as genetically modified foods and feeds. The department actively conducts research in the field of molecular and biochemical food safety. The aim is to identify mechanisms of action in order to develop specific options for action for consumer protection. For this purpose, modern molecular and cell biological methods are used in the department to identify new biological endpoints for the risk assessment of potentially risky substances (biomarker concept). In addition, innovative detection methods as well as strategies and methods for the molecular traceability and product identity of food are designed and applied.

The main research areas are:

  • Molecular mechanisms of food or nutritional toxicological substances (including nanoparticles) in humans with the focus on the identification of new molecular biomarkers with the help of proteomics and transcriptomics as well as chemical-analytical techniques
  • Human studies for biomarker identification and internal exposure determination
  • Investigation of the absorption of foreign food substances or nanoparticles in the gastrointestinal barrier
  • Development of effect-related cell-based test systems for effect-related analysis
  • Development and validation of new molecular biological approaches for tracing food-related allergens and animal proteins in feed

Two reference laboratories are located in the department:

  • the National Reference Laboratory for Animal Proteins in Feed and
  • the reference laboratory in the European network of genetically modified organisms (GMO)

The department oversees the following BfR commissions:

  • Nutrition, dietetic products, novel foods and allergies
  • Genetically modified food and feed
  • Food additives, flavorings and processing aids

Employees represent the BfR in national and international specialist bodies (including ALS, SKLM, EFSA-ANS-Panel, EFSA-NDA Panel, EFSA-GMO-Panel, EFSA Working Groups, ENGL, Codex Alimentarius) and they represent Germany in EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed.

Department 5 includes four specialist groups:

  • Division 51: Effect-related analysis and toxicogenomics
  • Section 52: Food Toxicology
  • Section 53: Nutritional Risks, Allergies and Novel Foods
  • Section 54: Risks of Particular Population Groups and Human Studies.

Pesticide safety

The task of the department includes the health risk assessment of pesticides and biocidal products, which are grouped under the heading of pesticides after the structural adjustment in the BfR, in accordance with the requirements of Directive (EC) No. 2009/128 / EC on a Community framework for the sustainable use of pesticides. The main tasks of the department include the determination of the inherent toxic properties and dose-effect relationships, the classification and labeling of pesticide active ingredients and their metabolites, the derivation of toxicological limit values, the determination of the exposure of humans, farm animals and domestic animals and finally the health Risk assessment with the aim of avoiding harmful effects on human and animal health. Furthermore, risk management options for the derivation of risk reduction measures and maximum residue levels are developed, analytical monitoring methods are checked and regulatory testing and evaluation strategies and technical guidelines are newly and further developed. The evaluation takes the form of scientific statements, contributions or comments on evaluation reports. Regulations and risk management measures in national, European and worldwide regulatory approval, approval and assessment procedures are based on the health risk assessments for the active ingredients and formulated preparations prepared in the department:

  • Regulation (EC) No. 1107/2009 on the placing of plant protection products on the market (PPE Regulation),
  • Regulation (EC) No. 528/2012 on the making available on the market and use of biocidal products (Biocidal Regulation),
  • Regulation (EC) 396/2005 on maximum levels of pesticide residues (RHG-VO) and
  • of Regulation (EC) 1272/2008 on the classification, labeling and packaging of substances and mixtures (CLP-VO).

The department's research is primarily focused on supporting regulatory processes, currently particularly in the areas of alternative methods for evaluating metabolites and combination effects and evaluation principles of dermal absorption, processing factors and endocrine disrupting effects of pesticides. In addition, the department provides technical advice to the federal government on national and European legislation on pesticide active ingredients, the approval of products and the use of pesticides and biocides. Department 6 includes the following five specialist groups:

  • Section 61: Control and Overall Assessment of Plant Protection
  • Section 62: Control and Overall Assessment of Biocides
  • Division 63: Toxicology of Active Ingredients and Their Metabolites
  • Division 64: Toxicology of Preparations and Safety of Use
  • Section 65: Residues and Analytical Techniques

Chemical and product safety

The Chemicals and Product Safety department evaluates chemical substances that fall under European chemicals law ( REACH Regulation (EC) 1907/2006). The aim is the toxicological assessment, the health risk assessment for consumers as well as the identification and initiation of necessary risk reduction measures acc. the REACH-VO. Assessments are also carried out with the aim of classifying and labeling dangerous substances in accordance with CLP Regulation (EC) 1272/2008.

Furthermore, the department works on the identification, research, evaluation and prevention of health risks in cosmetic products, tobacco products, consumer goods (food packaging, toys, feeding bottles, teats, cleaning and care products, articles of clothing etc.), as well as other "consumer-related products" (furniture , Mattresses, carpets, hobby products etc.). This not only takes into account the existing knowledge gaps in a scientifically based risk assessment, but also the concerns of the population in this area. Experimental projects on migration and exposure as well as the toxicity of chemical substances in these everyday products are an integral part of the assessment work.

The tasks of the department also include the coordination and overall evaluation of the risk assessments, the identification of research needs for risk assessments and the initiation and support of internal and external research projects to support the risk assessments.

The employees of the department represent the BfR in national and international bodies, e.g. B. at the OECD, the WHO / IPCS, the European Food Safety Authority ( EFSA ), the European Chemicals Agency ( ECHA ), the EU Scientific Committee on Consumer Safety (SCCS), the Committee of Experts on Cosmetic Products of the Council of Europe, or in the BfR commissions for consumer goods (BeKo) and cosmetic products (KoKo) and in various working groups (e.g. the ALS, working group of food chemical experts) as well as national and international standardization committees.

Department 7 includes the following specialist groups:

  • Section 71: Control and Overall Assessment
  • Division 72: Chemical Safety
  • Section 73: Safety of products without food contact
  • Division 74: Safety of products with food contact
  • Section 75: Product Properties and Nanotechnology

Security in the food chain

One of the focal points of the work of the Department of Safety in the Food Chain is the assessment of the risks arising from the ingestion of contaminants, residues and other undesirable substances in food and feed.

The department is assigned the national reference laboratories for dioxins , PCBs and mycotoxins in food and feed, marine biotoxins, additives in animal nutrition and the senior expert body for import control of wine.

Strategies and methods for checking the authenticity of foods are being developed within the focus on product identity and traceability. Tasks in the field of pharmacologically active substances and veterinary drugs are the risk assessment of human and veterinary drug residues in food of animal origin, the assessment and opinion on residues with pharmacological effects in the context of advising federal and state authorities as well as the management of projects for residue analysis and assessment .

In addition, the department also conducts research, for example in the further development of concepts for the detection of potentially toxic substances and their metabolites in food and feed.

The following specialist groups are established in the department: "Residues", "Contaminants", "Product identity, product chains and traceability", "Feed and feed additives"

Experimental Toxicology and ZEBET

The Department of Experimental Toxicology and ZEBET is divided into five specialist groups: "ZEBET database and information procurement", "ZEBET alternative methods to animal experiments", "Animal welfare and laboratory animal science", "Toxicological assessment strategies, animal husbandry", "Aquaculture and reference material".

The department's assessment and research activities focus on the federal government's scientific questions on toxicological findings on the mode of action of chemical substances. Methodological and modeling approaches and evaluation strategies are in the foreground.

The BfR also has the national task of documenting and evaluating alternative and supplementary methods to animal experiments and recommending or enforcing their recognition nationally and internationally. This is done in the area of ​​responsibility of the federal government via ZEBET - this is the central office for recording and evaluating alternative and supplementary methods to animal experiments . An important task of ZEBET is the experimental validation of animal-free methods in order to achieve their inclusion in international regulatory, safety-toxicological test guidelines. The central office also carries out its own research work and, through a special budget, specifically funds projects for the development of alternative methods from other institutions.

Through the work of ZEBET, the BfR advocates nationally and internationally, in particular, wherever possible, replacing legally prescribed animal experiments with alternative examination methods.

Order of the BfR

The central task is consumer health protection . With its work, the institute should contribute to making food, substances and products safer and thus protecting the health of consumers. Science in the service of man is the guiding principle.

Research-based approach

The BfR conducts its own research on topics that are closely related to its assessment tasks in consumer health protection and food safety. The Federal Institute works scientifically with other international institutions and organizations as well as with the institutions of other countries that are active in consumer health protection and food safety. The BfR is also a member of the working group of departmental research institutions in Germany. Another focus is the cooperation with the European Food Safety Authority ; for these, the BfR is the national German contact point.

The state and federal authorities responsible for risk management can access the institute's health assessments and options for action. The work results and recommendations of the BfR serve all interested parties, such as science, industry and trade associations, trade, non-governmental organizations, consumer advice centers , the media, national and international bodies and organizations and also the interested consumer, as an important decision-making aid for measures. With its science-based risk assessment, the BfR provides important impetus for consumer health protection inside and outside Germany.

Risk assessment

Risk assessment, risk management (see BVL ) and risk communication are legally ( Regulation (EC) No. 178/2002 ) separate activities. The health risk assessment for the food and feed sector as well as for cosmetics, everyday products and chemicals is the responsibility of the BfR in Germany. In doing so, the BfR uses legal assessment criteria based on internationally recognized assessment standards and principles.

In terms of food and feed safety, risk assessment is understood to be a risk-oriented assessment that aims to characterize a hazard and assess its possible realization and severity for the affected group of consumers (one also speaks of exposure assessment), which is considered to be a food or feed runs out. Publicly discussed topics are often taken up and the objective is to present the facts as objective and understandable as possible. However, the BfR also researches and evaluates at the request of authorities, for example if there are (yet) no laws on a risk.

In order to ensure that the assessment principles of health risk assessments are transparent and comprehensible, the BfR has published guidelines for health assessments in consumer protection.

The professional independence and the science-based risk assessment are intended to ensure that the BfR's health risk assessments are not influenced by political, economic and social interests.

Risk communication

One of the tasks of the Federal Institute for Risk Assessment is risk communication with the aim of providing citizens with information about food safety and product safety according to the three principles of transparency, reliability and openness.

National and Europe-wide tasks

17 National Reference Laboratories (NRL) from the field of food safety and food hygiene and the senior expert body for wine with comparable tasks are located in the BfR . They were appointed by the federal government on the basis of European or national legislation. The national reference laboratories take on a pioneering role in the field of analytical-diagnostic methodology, and they are the national link between the Community reference laboratories of the EU and the enforcement laboratories of the monitoring of the countries.

The GLP Federal Agency is responsible for the coordination and harmonization of GLP-relevant questions in the national and international area as well as for the monitoring of certain GLP test facilities at home and abroad.

As the central national contact point (EFSA Focal Point) , the BfR coordinates the exchange of scientific information between the European Food Safety Authority (EFSA) and the authorities responsible for food and feed safety in Germany as well as stakeholders from the fields of business, politics, science and consumer associations. The BfR was proposed for this by the Federal Ministry of Food and Agriculture (BMEL). National focal points have been set up in all 28 member states of the European Union (EU). They are the interface between the national authorities of the Member States and EFSA. This is intended to coordinate and coordinate the risk assessment activities in the individual member states at European level. The aim is to pool the existing European knowledge about health risks in food and thus to ensure food safety in Europe at the highest scientific level.

The National Breastfeeding Commission , previously located at the BfR, has the task of promoting breastfeeding in Germany. Since April 1, 2019, it has been based at the Max Rubner Institute .

External expertise

The institute has set up 15 national expert commissions. The task of the commissions, which i. d. It usually meets twice a year, consists of advising the BfR on conceptual and methodological issues and the external scientific quality assurance of the BfR. The voluntary commission members are not involved in the official task of risk assessment. The decisions of the commissions are of an advisory nature for the BfR. In this way, the BfR commissions differ fundamentally from the commissions (panels) of the European Food Safety Authority (EFSA). With regard to its panels, the EFSA follows different principles than the BfR, since the panels prepare the EFSA risk assessments.

With its commissions, the BfR wants to bundle the expertise available in Germany at the highest possible scientific level. In the event of a crisis, the commissions guarantee quick access to a network of experts. The external experts come from universities and other research institutions, federal and state authorities, business and consumer associations, private laboratories and industry. You will be appointed for a period of three years (from 2014 for four years) by the appointment advisory board - this consists of members of the Scientific Advisory Board of the BfR, the respective chairmen of the senate commissions for the health assessment of food as well as for substances and resources in agriculture of the German Research Foundation (DFG) and a representative of the Senate of the Federal Research Institutes. The committee members are published on the BfR website.

Since the BfR is aware of the problem of a possible conflict of interest of the external experts, the interested experts must commit themselves when applying to act independently as commission member in the public interest. Any conflicts of interest on topics dealt with in the BfR commissions are recorded in writing. To this end, the members sign a corresponding declaration, which is published on the BfR website. In addition, any conflicts of interest are verbally queried at the beginning of each committee meeting and noted in the minutes of the results. The minutes are published on the BfR website.


The independence of the results and risk communication of scientific risk assessments by the BfR from the superior Federal Ministry of Food and Agriculture is intended by the legislature. The experience of the BSE crisis with its dramatic loss of confidence in political action prompted the German Bundestag to introduce the BfR, as the independent voice of science, into the processes of public and parliamentary policy advice. This was also anchored in the BfR Founding Act (Section 2 (3) BfRG). For reasons of independence, the BfR does not raise any financial resources from industry. In order to ensure an independent risk assessment, the BfR has drawn up rules for the independence of its scientists.

The overall concept of risk assessment and communication by the BfR provides for an exchange with all stakeholders (NGOs, consumer associations, business, politics, science, the media). In particular, when different scientific positions are represented and justified, the participation of different stakeholders is of great importance. This is also reflected in the many BfR events as part of the scientific dialogue, such as BfR consumer protection forum, BfR stakeholder conferences, BfR symposia and seminars, user conferences, specialist conferences, committee and committee meetings, working group meetings, specialist and expert discussions, and expert discussions , Workshops etc.

On the occasion of its 10th anniversary on November 20, 2012, the institute dealt with the topic of “Independence and Conflicts of Interest” and organized the European Stakeholder Conference “How Independent Can Science Be?”.

The public discussion on independence and possible conflicts of interest is always necessary, especially when it comes to socially controversial issues. The German Bundestag, for example, has dealt with possible conflicts of interest and possible technical bias in the risk assessment of genetically modified organisms and plant protection products. The federal government answered a question from parliament.


In the area of ​​food and feed safety, the BfR works closely with the "European Food Safety Authority" ( EFSA ) and its European sister authorities. The EU food safety almanac compiled by the BfR provides an overview of these authorities . Internationally, the BfR cooperates with the “ Codex Alimentarius ”, a joint commission of the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO), which develops international food standards for the protection of consumers. In the area of ​​feed, food and product safety, global trade is already in fact globalized. That is why the BfR is networked nationally and worldwide with a large number of scientific sister and partner organizations through cooperation agreements. The aim is scientific collaboration in risk assessment and a. of food and feed as well as the exchange of scientists and scientific knowledge.

The BfR has concluded cooperation agreements with the following institutions:

  • Brazil: National Health Surveillance Agency ( ANVISA ) (contract signed 2012)
  • Bulgaria: Bulgarian Food Safety Authority (BFSA) (contract signed 2014)
  • Denmark: National Food Institute of the Danish Technical University (DTU) (contract signed in 2010, renewed in 2013, together with ANSES, France)
  • Estonia: Ministry of Agriculture (PM) (contract signed in 2015)
  • Finland: Finnish Food Safety Agency (Evira) (contract signed 2015)
  • France: French Authority for Food and Environment and Labor Protection ( ANSES ) (contract signed 2010, renewed 2013, together with DTU, Denmark)
  • China: Chinese Academy of Inspection and Quarantine (CAIQ) (contract signed 2009), China National Center for Food Safety Risk Assessment (CFSA) (contract signed 2012), Chinese Academy of Agricultural Sciences (CAAS) (contract signed 2012), China Animal Health and Epidemiology Center (CAHEC) (contract signed 2013)
  • India: Food Safety and Standards Authority of India (FSSAI) (contract signed 2015)
  • Iceland: Icelandic Food and Veterinary Authority (MAST) (contract signed 2012), Icelandic Food and Biotech Research Institute (MATIS Ltd.) (contract signed 2012),
  • Republic of Korea (South Korea): Korea Food and Drug Administration (KFDA) and National Institute of Food and Drug Safety Evaluation (NIFDS) (contract signed in 2010),
  • Croatia: Croatian Food Safety Authority (HAH) (contract signed 2009),
  • Latvia: Food and Veterinary Service of Latvia (PVD) (contract signed 2005), Institute of Food Safety, Animal Health and Environment (BIOR) (contract signed 2012),
  • Lithuania: National Food and Veterinary Risk Assessment Institute (NFVRAI) (contract signed 2008, renewed 2013), State Food and Veterinary Service (VMVT) (contract signed 2008),
  • Montenegro: Ministry of Agriculture and Rural Development (MPR) (contract signed in 2015),
  • Netherlands: Dutch Food and Consumer Product Safety Authority (NVWA) (contract signed in 2006),
  • Austria: Austrian Agency for Health and Food Safety (AGES) (contract signed 2006),
  • Poland: National Veterinary Research Institute (PIWET) (contract signed in 2012)
  • Portugal: Economic and Food Safety Standards Authority (ASAE) (contract signed in 2015)
  • Russia: Russian Federal Center for Hygiene and Epidemiology (FGUS) and Research Institute for Nutrition of the Russian Federation (RAMN) (contract signed in 2009),
  • Uruguay: Department for Planning and Coordination of Food Safety (UCPIA) of Uruguay's Ministry of Agriculture and Fisheries (contract signed 2014),
  • Cyprus: Cyprus State General Laboratory (contract signed 2010).

Since 2005, the Federal Institute has agreed to work closely with the Stiftung Warentest in Berlin in order to make progress in consumer health protection .


The ZDFzoom report Das Stille Poison from May 8, 2013 took the position that the institute does not assess pesticides such as glyphosate with the help of independent experts and that the BfR's assessments are not independent studies, but mainly studies commissioned by manufacturers such as Monsanto even studies of unknown origin without information on the authors were used. The Federal Institute for Risk Assessment has been criticized for years. The BfR was again accused of a lack of independence and conflicts of interest in 2012 by the organizations Testbiotech and LobbyControl. In 2012, the German Bundestag also dealt with possible conflicts of interest and possible technical one-sidedness in the risk assessment of genetically modified organisms and plant protection products. On July 23, 2012 and July 29, 2015, the Federal Government gave a detailed answer on the independence of the BfR (German Bundestag, printed matter 17/10373 and German Bundestag, printed matter 18/5347) (see also section “Independence of the BfR”). In November 2017, in an interview with the Berliner Tagesspiegel , BfR President Hensel rejected allegations of plagiarism as part of the glyphosate approval as follows: “ Anyone who claims that we have written off should simply read the content of the 4500 pages that we have submitted. We explained how we proceed in a completely transparent manner. "

In March 2019, the BfR took legal action against the transparency platform FragDenStaat.de . With the application for an interim injunction at the Regional Court of Cologne , the Federal Office achieved that the platform had to delete a glyphosate report from the office that it had previously received via a request under the Freedom of Information Act. More than 38,000 people then asked the Federal Institute for the report. In 2018, the BfR already spent around 80,000 euros on legal fees to prevent the MDR from reporting. Both the Cologne Regional Court (file number: 14 O 302/15) and the Cologne Higher Regional Court (file number: 6 U 8/17) ruled in favor of the BfR in the preliminary injunction proceedings. The main proceedings are currently pending. The Federal Government said in the person of Parliamentary State Secretary Michael Stübgen on April 3, 2019 in the 91st plenary session with a view to the legal dispute between the BfR and FragDenStaat.de that it saw no reason to work towards a change in the law. On July 4, 2019, the Cologne Regional Court lifted the preliminary injunction due to a formal error . Since then, the glyphosate report can be published again.

additional information

Aspects of quality assurance

The legal regulations for quality assurance of licensing-relevant toxicological studies are of essential importance. Approval processes around the world are based on the principle that whoever wants to bring a product to market pays for all the necessary toxicological studies so that the taxpayer does not incur any costs. Studies, information and documents relating to the product must be submitted to the responsible authorities. The scientists working at the BfR expertly examine the approval documents. For example, they assess whether the studies adhere to international scientific guidelines and quality standards, meet methodological data requirements and are relevant to practice.

The toxicological studies relevant to approval in the field of plant protection must meet the requirements and standards of the following legal regulations:

Selected legal sources for evaluation work in the field of plant protection

Toxicological assessment of chemical substances

Which toxicological studies are required for the respective active substances or preparations of plant protection products is stipulated by law in EU Directive 91/414 / EEC and for new tests to be carried out in Regulation (EC) No. 1107/2009 (Plant Protection Product Regulation) . The specification of the data requirements according to Regulation (EC) No. 1107/2009 of the European Parliament and of the Council on the placing of plant protection products on the market is for active substances in Regulation (EU) No. 283/2013 of the Commission of March 1, 2013 and for Plant Protection Products Regulation (EU) No. 284/2013 of the Commission of March 1, 2013.

Animal testing

For animal experiments, the decisive factor is whether the studies comply with the internationally recognized guidelines in terms of their design, the animal species used, the number of animals used, the examined parameters and the way they are presented. How the studies are to be carried out is described in the Test Method Regulation (EC) No. 440/2008 , which is based on the OECD guidelines on toxicological test methods for chemicals; the quality of the studies is checked by the changeable Good Laboratory Practice (GLP).

Legal proceedings in the field of plant protection

As a basis for national approvals of plant protection products, two fundamental decisions are made beforehand at EU level, which then apply in all EU member states :

EU testing of active substances and determination of maximum residue levels

At EU level it is decided 1) which active ingredients may be used in plant protection products in Europe (EU active ingredient test), 2) which maximum residue levels on food apply to all active ingredients.

According to Section 41 of the Plant Protection Act, the BfR is involved in both European procedures with regard to human and animal health, the avoidance of damage to health through soil pollution and the analysis methods for residues. In these procedures, a member state initially takes on the task of checking and evaluating all the information submitted and researched by the applicant. This rapporteur Member State ( english Rapporteur Member State, RMS ) created a draft assessment report to all other Member States will be submitted for comment. This so-called peer review process is organized by the European Food Safety Authority (EFSA). The final decision on the inclusion of an active ingredient in Annex I (positive list according to Directive 91/414 / EEC) or the approval of an active ingredient according to Regulation (EC) No. 1107/2009 or on the setting of maximum residue levels according to Regulation (EC) No. 396/2005 is taken by the Standing Committee on the Food Chain and Animal Health (SCFCAH) of the European Commission.

Example glyphosate :

The active ingredient glyphosate was included in the EU list of active ingredients in 2002 for the usual period of 10 years. In November 2010 the EU Commission decided to extend the approval of glyphosate until the end of 2015.

The active ingredient glyphosate is currently being reassessed as part of the EU active ingredient testing. The rapporteur Member State is Germany. A comprehensive report is prepared for the reassessment. Approx. 2000 documents (original studies, published scientific literature, abstracts) are available for examination. The draft evaluation report is to be commented on by the other Member States in 2014. On the basis of the assessment report, taking into account the comments received, a decision will be made on the further approval of the active ingredient glyphosate. In addition to the BfR, the Federal Environment Agency and the Julius Kühn Institute, as well as the Federal Office for Consumer Protection and Food Safety as the risk management authority, are also involved in the re-evaluation.

The regular reassessment of active ingredients is a routine procedure to ensure that new research results can always be incorporated into the assessment.

National approval process for plant protection products

Plant protection products consist of one or more active ingredients as well as so-called co-formulants (such as solvents or active enhancers). Companies that want to bring plant protection products onto the market must first apply for their national approval. The approval of plant protection products is carried out in accordance with the Plant Protection Act and relevant European regulations by the Federal Office for Consumer Protection and Food Safety (BVL) with the participation of the Julius Kühn Institute (JKI), the Federal Environment Agency (UBA) and the BfR, the partial assessments within the scope of their legally assigned responsibilities carry out. They check the extensive studies submitted by the companies with the applications on the effectiveness, toxicology, residue and environmental behavior of the pesticides, etc.

The data requirements stipulated by law (cf. the above-mentioned “Legal Regulations for Quality Assurance of Approval-Relevant Toxicological Studies”) are so extensive that the active substances contained in plant protection products are among the best-examined chemical substances. The BfR assesses the health risks of plant protection products for all groups of people who may come into contact with the product and its components. The BfR guarantees that suitable analytical methods are available to monitor residues of the pesticide in food, body fluids and in the environment.

See also

Web links

Commons : Federal Institute for Risk Assessment  - collection of images, videos and audio files

Individual evidence

  1. General information on the BfR homepage
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  10. Structure overview of the BfR. Retrieved August 13, 2018 .
  11. Exposure Department - BfR. Retrieved August 13, 2018 .
  12. Legal tasks - BfR. Retrieved August 13, 2018 .
  13. Regulation (EC) No. 1107/2009 of the European Parliament and the Council , accessed on August 31, 2018
  14. Regulation (EU) No. 528/2012
  15. Regulation (EC) No. 396/2005
  16. Regulation (EC) No. 1272/2008
  17. ^ Department of Pesticide Safety - BfR. Retrieved August 13, 2018 .
  18. ^ Department of Chemicals and Product Safety - BfR. Retrieved August 13, 2018 .
  19. ^ Department of Safety in the Food Chain - BfR. Retrieved August 13, 2018 .
  20. Department of Experimental Toxicology and ZEBET - BfR. Retrieved August 13, 2018 .
  21. https://www.bfr.bund.de/de/das_bundesinstitut_fuer_risikoberung__bfr_-280.html
  22. Cooperations - BfR. Retrieved August 13, 2018 .
  23. ^ Members of the focal points and observers . In: European Food Safety Authority . ( europa.eu [accessed August 13, 2018]).
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  25. Guide to Health Assessments. (PDF) 2010, accessed on August 13, 2018 .
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  27. ^ Website of the National Breastfeeding Commission ( Memento from June 27, 2015 in the Internet Archive ).
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  29. BfR Commissions - BfR. Retrieved August 13, 2018 .
  30. Questions and answers on ensuring the independence of the Federal Institute for Risk Assessment - BfR. Retrieved August 13, 2018 .
  31. European Stakeholder Conference “How Independent Can Science Be?” Incl. Ceremony for the 10th anniversary of the BfR and opening of the exhibition "The History of Consumer Health Protection" - BfR. Retrieved August 13, 2018 .
  32. a b Answer of the Federal Government to the Bundestag on "Conflicts of interest and technical one-sidedness in the risk assessment of genetically modified organisms and plant protection products": (PDF) Retrieved August 13, 2018 .
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  34. EU Almanac Food Safety. (PDF; 12 MB) Retrieved on August 13, 2018 .
  35. Overview of the BfR cooperation. Retrieved August 13, 2018 .
  36. CAIQ - BfR. Retrieved August 13, 2018 .
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  39. ^ Cooperation agreement between the BfR and the Lithuanian National Food and Veterinary Risk Assessment Institute (NFVRAI) renewed - BfR. Retrieved August 13, 2018 .
  40. ^ Cooperation between the BfR and Austria. Retrieved August 13, 2018 .
  41. ^ Cooperation between the BfR and Russia. Retrieved August 13, 2018 .
  42. Cooperation between the BfR and Cyprus. Retrieved August 13, 2018 .
  43. ^ Stiftung Warentest and BfR sign cooperation agreement , BfR, October 21, 2005, accessed on February 21, 2014.
  44. Naturally Real: Roundup (Glyphosate) - The silent poison. (Video) ZDF Zoom report, May 20, 2013, accessed on August 13, 2018 .
  45. Silvia Liebrich: How a lobby infiltrates the control authorities . In: sueddeutsche.de . 2012, ISSN  0174-4917 ( sueddeutsche.de [accessed on August 13, 2018]).
  46. Nicolai Kwasniewski: Possible influence on federal institutes: lobby guards reprimand the power of the gene food industry . In: Spiegel Online . May 25, 2012 ( spiegel.de [accessed on August 13, 2018]).
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  49. Censorship law: Cologne Regional Court forces FragDenStaat to delete state glyphosate reports (update). In: FragDenStaat.de. Retrieved April 6, 2019 .
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Coordinates: 52 ° 31 ′ 51.9 ″  N , 13 ° 17 ′ 49.4 ″  E