BfRshort forGerman Federal Institute for Risk Assessment recommendations: Scientific guidance on health protection for consumers

The BfRshort forGerman Federal Institute for Risk Assessment is a External Link:scientifically independent public-law institution. Its central task is the scientific risk assessment of food and feed, as well as of chemicals and consumer products, as a basis for the German Federal Government’s consumer health protection. The Institute advises the Federal Ministry of Agriculture, Food and Regional Identity (BMLEH), the Federal Ministry for the Environment, Climate Action, Nature Conservation and Nuclear Safety (BMUKN) and, to some extent, other senior federal authorities.

To this end, the Institute prepares, amongst other things, scientific reports and opinions. The BfRshort forGerman Federal Institute for Risk Assessment has a scientific advisory role and, in this capacity, is also involved in a range of notification and authorisation procedures.

What is not part of the BfR’s mandate is the so-called risk management, i.e. for example the setting of legally binding limit values or restrictions on the use of certain substances, as well as the enforcement and monitoring of statutory limit values. Responsibility for risk management lies with various federal and state ministries and authorities, as well as institutions within the European Union. This institutional separation between risk assessment and risk management is central to ensuring scientific independence, transparency and trustworthiness.

Through independent scientific assessment, research and the transparent communication of health risks, the BfRshort forGerman Federal Institute for Risk Assessment contributes impartially to the safety of food and feed, consumer products and chemicals. The opinions present the existing knowledge on health risks in a transparent and objective manner. They reflect the current state of science and technology at the time of publication.

As conclusions to its scientific opinions, the BfRshort forGerman Federal Institute for Risk Assessment also derives recommendations for action for consumers, legislators, the competent implementing authorities and economic operators.

The recommendations in the scientific opinions on various health issues differ from the so-called ‘BfRshort forGerman Federal Institute for Risk Assessment Recommendations on Food Contact Materials’, which the BfRshort forGerman Federal Institute for Risk Assessment develops and publishes independently as a separate category of documents. Information on this can be found under the question ‘What are the “BfRshort forGerman Federal Institute for Risk Assessment Recommendations on Food Contact Materials”?’

The recommendations contained in scientific opinions are aimed at consumers, risk management bodies and economic operators. Derived values are generally the result of a hazard and/or risk assessment.

The recommendations have no legal effect and are therefore not legally binding. Failure to comply with them does not necessarily mean that products violate applicable laws or are not marketable. In certain cases, however, BfRshort forGerman Federal Institute for Risk Assessment assessments may be used to demonstrate breaches of the law – for example, if exceeding a value derived by the BfRshort forGerman Federal Institute for Risk Assessment poses a health risk. Furthermore, BfRshort forGerman Federal Institute for Risk Assessment recommendations may indicate how the described health risks could be addressed.

Only the relevant national and European legislation is legally binding, such as food law, consumer protection law or product safety law.

In statements to federal ministries, the BfRshort forGerman Federal Institute for Risk Assessment formulates recommendations as part of its scientific policy advice and in accordance with its External Link:guidelines for the assessment of health risks. These recommendations serve to contextualise assessment results, highlight possible courses of action from a scientific perspective and make their health consequences transparent. The decision as to whether and how these recommendations are translated into policy action or administrative acts rests solely with the competent risk management authorities.

The External Link:BfR recommendations on food contact materials have been published by the BfRshort forGerman Federal Institute for Risk Assessment and its predecessor institutions since 1958 and are regularly updated. They relate to materials and articles that come into contact with food. Based on the current state of science and technology, they describe the conditions under which certain substances are suitable for the manufacture of food contact materials from a health perspective.

These recommendations are not legally binding either. In practice, however, they are frequently used as a recognised scientific standard and complement existing legal regulations at national and EU level. Manufacturers and traders are legally obliged to place only safe products on the market. Adherence to BfRshort forGerman Federal Institute for Risk Assessment recommendations is voluntary, but offers a scientifically recognised basis for doing so.

Originally, the recommendations dealt primarily with substances used in the manufacture of plastics for food contact. For this reason, they were long referred to as the ‘BfR plastic recommendations’. However, this area is now regulated almost exclusively at European level.

Detailed information on the BfRshort forGerman Federal Institute for Risk Assessment recommendations for food contact materials External Link:can be found in a separate FAQ.

To date, there are no EU-wide binding maximum levels for the use of vitamins and minerals in food supplements and fortified foods. The BfRshort forGerman Federal Institute for Risk Assessment has therefore drawn up recommendations for maximum levels. These are intended to ensure that food supplements and fortified foods enable a significant additional intake of nutrients, whilst at the same time protecting the majority of the population, who are already well supplied with nutrients, from excessive and potentially harmful nutrient intake. The recommended maximum levels are intended as a guide for consumers when using such products. They are also intended to provide the competent authorities with options for action and ultimately to serve as a scientific basis for the establishment of statutory maximum level regulations at EU level. The proposed maximum levels should not be confused with statutory limit values.